CLASS II Drug recall · Reported 15 Jun 2022 · FDA Enforcement Report
Homeopathic EarAche Drops recalled by Grato Holdings
Grato Holdings is recalling Homeopathic EarAche Drops, distributed nationwide in the US. The recall was initiated on 24 May 2022 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0989-2022
- FDA event ID
- 90297
- Recalling firm
- Grato Holdings, Woodbine, IA
- Manufacturer
- Rite Aid Corporation
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 May 2022
- FDA classified
- 8 Jun 2022
- Reported
- 15 Jun 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
Timeline
| 24 May 2022 | Recall initiated by company | |
| 8 Jun 2022 | Classified by FDA | +15 days |
| 15 Jun 2022 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Microbial contamination of non-sterile product.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Homeopathic EarAche Drops, 0.33 FL OZ (10 mL) bottles, Distributed by: RITE AID, 30 Hunter Lane, Camp Hill, PA 17011. NDC 11822-3644-3
Where it was distributed
Nationwide within the USA
Stores named: Rite Aid
Questions about this recall
Why was it recalled?
Microbial contamination of non-sterile product.
Which lots are affected?
Lot #: G11639, Exp. Date 09/24
Where was it sold?
Nationwide within the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 90297| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Homeopathic EarAche Ear Drops recalled by Grato Holdings | Grato Holdings | Sterility | Nationwide | |
| CLASS II | Earache Drops recalled by Grato HoldingsWalgreens Earache Drops | Grato Holdings | Sterility | Nationwide |
More recalls from Grato Holdings
All 20| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Food | CLASS II | BioActive Nutritional Minaplex, Botanical Herbal Supplement recalledBioActive Nutritional | Grato Holdings | Mold | Nationwide |
| Food | CLASS II | Energique Mineral Magic Dietary Supplement recalled by Grato HoldingsEnergique Mineral | Grato Holdings | Mold | Nationwide |
| Drug | CLASS III | V-force Homeopathic recalled by Grato Holdings | Grato Holdings | Packaging Defects | FL |
| Drug | CLASS II | Earache Drops recalled by Grato HoldingsWalgreens Earache Drops | Grato Holdings | Sterility | Nationwide |
| Drug | CLASS II | Homeopathic EarAche Ear Drops recalled by Grato Holdings | Grato Holdings | Sterility | Nationwide |